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# FDA Approves Daxxify for Frown Lines
- URL: https://www.fdaweb.com/fda-approves-daxxify-for-frown-lines/
- Published: 2022-09-08T12:00:00.000Z
- Updated: 2026-09-14T17:58:42.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152699

FDA has approved a Revance Therapeutics BLA for Daxxify (daxibotulinumtoxinA-lanm) for injection for temporarily improving moderate-to-severe frown lines (glabellar lines) in adults. The product, which will compete against Allergan’s Botox, is being touted as the first long-acting neuromodulator that “demonstrates a median duration of six months and up to nine months for some patients,” according to the company. It says conventional neuromodulators have a three- to four-month duration profile.

Approval was based on data from the SAKURA Phase 3 clinical trial program (SAKURA [1,](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03014622%3Fterm%3DDaxibotulinumtoxinA&esheet=52874144&newsitemid=20220908005320&lan=en-US&anchor=1%2C&index=1&md5=1e14752ccde742eb4bd64e323f0c081e&ref=fdaweb.com)[2,](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03014635%3Fterm%3DDaxibotulinumtoxinA&esheet=52874144&newsitemid=20220908005320&lan=en-US&anchor=2%2C&index=2&md5=8252c3352dbf1e2c9181aa376db614e7&ref=fdaweb.com)[3)](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03004248%3Fterm%3DDaxibotulinumtoxinA&esheet=52874144&newsitemid=20220908005320&lan=en-US&anchor=3%29&index=3&md5=7f9e270e57635d8525741b2f3ad2e79c&ref=fdaweb.com), that involved more than 2,700 patients and about 4,200 treatments. Data showed that 74% of treated patients achieved a greater than two-grade improvement in glabellar lines at week four as assessed by both the patient and clinical investigator, Revance says. It also showed that 98% of subjects achieved none or mild wrinkle severity at week four 4 (investigator assessments).

The company says data showed that Daxxify is safe and well tolerated with no serious treatment-related adverse events reported in the clinical trials, and “has a safety profile consistent with other currently available neuromodulators in the esthetics market. The most common treatment-related adverse events with Daxxify observed in the pivotal trials were headache (6%) followed by eyelid ptosis (2%) and facial paresis, including facial asymmetry (1%).”